The following data is part of a premarket notification filed by Advanced Cardiovascular Systems, Inc. with the FDA for Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter.
Device ID | K844972 |
510k Number | K844972 |
Device Name: | ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER |
Classification | Catheter, Angioplasty, Peripheral, Transluminal |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
Contact | Jane E Beggs |
Correspondent | Jane E Beggs ADVANCED CARDIOVASCULAR SYSTEMS, INC. 1500 SALADO DRIVE, SUITE 101 Mountain View, CA 04043 |
Product Code | LIT |
CFR Regulation Number | 870.1250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-24 |
Decision Date | 1985-05-16 |